HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
25 juni 2026 bijgewerkt door: HELP Therapeutics Co., Ltd.
A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery.
Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
This is a Phase I/IIa, open-label, dose-escalation study of HiCM-188 in adult participants with advanced heart failure. HiCM-188 is an investigational cell therapy product consisting of allogeneic human iPSC-derived cardiomyocytes intended for intramyocardial administration.
Eligible participants will receive HiCM-188 during coronary artery bypass grafting (CABG) surgery. The study uses a 3+3 dose-escalation design to evaluate two dose levels of HiCM-188: 0.5 × 10^8 cells and 1.5 × 10^8 cells. The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188. Secondary objectives include evaluation of preliminary efficacy based on cardiac function, myocardial perfusion, exercise capacity, NYHA functional classification, quality of life, and major adverse cardiac events.
Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.
Studietype
Ingrijpend
Inschrijving (Geschat)
12
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Alex Zhang
- Telefoonnummer: +1 650 504 5586
- E-mail: Alex.zhang@helptx.com.cn
Studie Locaties
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- The Texas Heart Institute at Baylor College of Medicine
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Hoofdonderzoeker:
- Emerson Perin
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Able to sign informed consent and comply with the study protocol
- 18 to 75 years old at the time of signing informed consent
- Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)
- Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa
- Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- Other criteria apply. Please contact the investigator for more information.
Exclusion Criteria:
- Viral myocarditis
- Amyloidosis
- Pericardial disorders or pericarditis
- Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
- Primary significant organic valvular heart disease, with specified dimensions
- Untreated congenital heart disease
- Complete atrioventricular (AV) conduction block
- History of left ventricular assist device surgery
- Other criteria apply. Please contact the investigator for more information.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: HiCM-188 Low Dose
Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
|
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
|
|
Experimenteel: HiCM-188 High Dose
Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
|
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of Serious Adverse Events
Tijdsspanne: Up to 12 months post-transplant
|
Incidence of serious adverse events (SAEs) at 12 months post-transplant
|
Up to 12 months post-transplant
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in left ventricular ejection fraction (LVEF, %) assessed by cardiac magnetic resonance imaging (MRI).
Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in left ventricular end-diastolic volume (LVEDV, mL) assessed by cardiac MRI.
Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in left ventricular end-systolic volume (LVESV, mL) assessed by cardiac MRI.
Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Infarct Size by Cardiac MRI
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in myocardial infarct size assessed by cardiac MRI.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in myocardial tissue perfusion assessed by positron emission tomography/computed tomography (PET/CT) or single-photon emission computed tomography (SPECT).
|
Baseline, 6 months, and 12 months
|
|
Incidence of Major Adverse Cardiac Events
Tijdsspanne: Up to 12 months post-transplant
|
Incidence of major adverse cardiac events (MACE) during the study follow-up period.
|
Up to 12 months post-transplant
|
|
Change From Baseline in 6-Minute Walk Distance
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in exercise capacity as assessed by the 6-minute walk distance (6MWD).
The 6-Minute Walk Distance is measured as the distance walked in 6 minutes, with longer distances reflecting better functional exercise capacity.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in New York Heart Association Functional Classification
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in New York Heart Association (NYHA) functional classification.
The New York Heart Association Functional Classification ranges from Class I to Class IV, with higher classes reflecting more severe limitation of physical activity and worse heart failure symptoms.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
Tijdsspanne: Baseline, 6 months, and 12 months
|
Change from baseline in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
The Minnesota Living With Heart Failure Questionnaire score ranges from 0 to 105, with higher scores reflecting worse heart failure-related quality of life.
|
Baseline, 6 months, and 12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 mei 2028
Studie voltooiing (Geschat)
1 mei 2028
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
12 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
25 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HICM188H1101
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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